UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063204 |
|---|---|
| Receipt number | R000072339 |
| Scientific Title | Observational Study of Secretory Immunoglobulin A (s-IgA) in IBD Patients and Control Subjects |
| Date of disclosure of the study information | 2026/10/10 |
| Last modified on | 2026/10/07 14:46:25 |
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Basic information
Public title
Observational Study of Secretory Immunoglobulin A (s-IgA) in IBD Patients and Control Subjects
Acronym
Comparison of salivary secretory immunoglobulin A (s-IgA) between IBD patients and healthy individuals.
Scientific Title
Observational Study of Secretory Immunoglobulin A (s-IgA) in IBD Patients and Control Subjects
Scientific Title:Acronym
Comparison of salivary secretory immunoglobulin A (s-IgA) between IBD patients and healthy individuals.
Region
| Japan |
Condition
Condition
Ulcerative colitis, Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to compare salivary IgA (s-IgA) levels between patients with IBD and individuals without IBD (controls) by assessing IBD symptoms and disease activity, and by measuring IgA in collected saliva and blood samples.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary s-IgA secretion rate (salivary s-IgA secretion velocity)
Key secondary outcomes
Complete blood count (CBC), serum IgA, serum IgG4, serum IgG, serum IgM, PR3-ANCA, serum LRG, serum CRP, fecal calprotectin, serum non-specific IgE, serum specific IgE (Japanese cedar, Japanese cypress, birch (genus), alder (genus), pine (genus), orchard grass, timothy grass, ragweed, mugwort)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Aged 20 to 80 years at the time of obtaining consent
2. Individuals who voluntarily consent to participate in the study after fully understanding its purpose and content
3. Individuals who meet either of the following criteria:
a) Diagnosed with IBD based on a physician's assessment
b) Free of IBD symptoms and with a fecal calprotectin level of 50.0 mg/kg or less
Key exclusion criteria
1. Individuals for whom saliva collection is difficult (e.g., due to xerostomia)
2. Individuals whose saliva may contain blood (e.g., due to oral conditions involving bleeding)
3. Any other individuals deemed unsuitable as study participants by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Taro |
| Middle name | |
| Last name | Osada |
Organization
Juntendo University Urayasu Hospital
Division name
Department of Gastroenterology
Zip code
279-0021
Address
2-1-1 Tomioka Urayasu Chiba
TEL
047-353-3111
otaro@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Taro |
| Middle name | |
| Last name | Osada |
Organization
Juntendo University Urayasu Hospital
Division name
Department of Gastroenterology
Zip code
279-0021
Address
2-1-1 Tomioka Urayasu Chiba
TEL
047-353-3111
Homepage URL
otaro@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
EP-DataWeave Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Urayasu Hospital Ethics Committee Secretariat
Address
2-1-1 Tomioka Urayasu Chiba
Tel
047-353-3111
rinri-urayasu@juntendo-urayasu.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will measure secretory IgA in the salivary glands of patients with ulcerative colitis and Crohn's disease and compare the results with those of healthy individuals to investigate whether it is a contributing factor to the onset of the disease or is associated with disease activity.
Management information
Registered date
| 2026 | Year | 10 | Month | 07 | Day |
Last modified on
| 2026 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072339
